Use Misoprostol to Optimize Prevention of Cervical Cancer

NCT ID: NCT06669533

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2027-11-04

Brief Summary

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This is a double-blind randomized controlled trial of 420 non-pregnant women undergoing cancer screening by visual inspection with acetic acid (VIA) who have Type 3 transformation zone (TZ) and randomized to receive either Misoprostol or placebo.

Detailed Description

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Conditions

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Cervical Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

The PIs, nurses who will be providing the drugs, and study participants will be blinded in the study.

Study Groups

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Non-pregnant women

Non-pregnant women will either receive 600 mcg misoprostol (3 tablets) or identical placebo 3 (tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Participants will receive placebo (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).

Misoprostol

Intervention Type DRUG

Participants will receive 600 mcg misoprostol (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).

Interventions

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Placebo

Participants will receive placebo (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).

Intervention Type DRUG

Misoprostol

Participants will receive 600 mcg misoprostol (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Type 3 TZ confirmed on exam prior to randomization
* Age 25 years or older

Exclusion Criteria

* With Type 1 or 2 TZ prior to randomization
* Currently pregnant
* History of hysterectomy
* Any cancerous lesions
* Active cervicitis
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cameroon Baptist Convention Health Core

UNKNOWN

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Warner Huh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Warner K Huh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Cameroon Baptist Convention Health Core, EtougEbe Baptist Hospital Yaoundé

Yaoundé, Center Region, Cameroon

Site Status RECRUITING

Countries

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Cameroon

Central Contacts

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Warner K Huh, MD

Role: CONTACT

2059341555

Simon M Manga, PhD

Role: CONTACT

2059345612

Facility Contacts

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Simon M Manga, PhD

Role: primary

2059345612

Warner K Huh, MD

Role: backup

2059341555

Other Identifiers

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1R01CA279021

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-30012879

Identifier Type: -

Identifier Source: org_study_id

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